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Just in from Howard’s Desk (wheel chair) …
I just sent a feedback message to med page. How ridiculous it is that the FDA is implementing 25 new actions, in order to help improve the medical device approval dilemma.
I said given the opportunity I would be willing to undertake a position as a lay person in the approval process of medical devices. Providing I could report directly to the president. This would save us, taxpayers, money by eliminating a lot of unnecessary bs. Rest a sure I wouldn’t need 25 new actions, I would get some people off their butts, and work.
All would have written job descriptions, if they didn’t follow them –out.
I would review 510k approvals back dating to 2005 -2011. Make sure all data, studies, etc. were in compliance with the product being approved. If they were not or if there were noticeable problems I would open my ears and listen and hear what doctors may be concerned about, and act accordingly.
There were some well known doctors that expressed concerns about metal on metal hip devices. Concerned about results that may occur if there should be particles shave from friction of these devices, even if they had plastic liners. These Dr’s were ignored and now look at the devastation going on in people’s lives.
Market share and financing seemed to take a precedence over the health and well being of people. This will only change if the bull is taken by the horns.
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